Definitely the right step: Arrive at a medical device or your own app with an experienced partner at your side. After all, operability, user friendliness, and faultlessness are of utmost relevance in medical engineering. We have been working in the field of application development for medical engineering as well as in UX engineering for a number of market leaders since 1992. We are the preferred supplier of Siemens Healthcare and have obtained EN ISO 13485 certification in 2011 in order to meet the stringent requirements related to the quality management system as a supplier for the manufacturers of medical devices. All to make your step into the future a sure success.
Take-off with maximum orientation
Success stories of our customers
FAU Erlangen-Nuremberg (Friedrich-Alexander-Universität Erlangen-Nürnberg)
„ASTRUM IT and my department of Pattern Recognition look back on years of successful and amicable cooperation in medical engineering. ASTRUM IT is therefore an important research partner of FAU Erlangen-Nuremberg from the medium-sized segment and did its bit in making our university one of the most innovative bodies of learning in the world. Thank you ever so much, dear ASTRUM IT team!"
Prof. Dr.-Ing. Joachim Hornegger
President of FAU Erlangen-Nuremberg (Friedrich-Alexander-Universität Erlangen-Nürnberg)
„Our cooperation with the employees of ASTRUM IT in the context of an efficient application of the latest AI technologies owes its success first and foremost due to their flexibility and commitment. The expertise of our contact persons went far beyond any standard. They perfectly complemented our team in designing and implementing new technical processes.
Dr. Sabine Häussermann
CEO, VisionHealth GmbH
„ASTRUM IT is our partner in the rapid prototyping of the new graphic user interface of our CT scanners. This enables an iterative and highly effective process in the entire concept design and definition of the user interface.
Moreover, we use the expertise of ASTRUMIT to evaluate the UI. In addition to the quantitative and qualitative assessment of the interface, the user experience is analysed in this process. The evaluation results deliver important input for the further development.
ASTRUM IT accompanies our UI development process holistically from UI concept design to prototyping and usability tests whose results are integrated in new concepts.“
Team Manager with Siemens Healthcare
The art of healthcare IT
Healthcare IT solutions are part of our key competences. In agile teams we develop software for image-processing systems in magnetic resonance and computer tomography, among others. And at the heart of our work? We develop target-, needs-, and quality-oriented software pursuant to the requirements of EN ISO 13485. We know what healthcare is all about. Risk management, usability, and traceability are top priority here. Particularly for the use of software for medical equipment, proven standard-compliant development is required.
Usability engineering at its best
As far as medical devices are concerned, legislation requires a usability-oriented development process according to the IEC EN 62366 standard. Our experts have mastered these requirements for nearly 25 years.
1. Usability File
- We see to it that the usability file meets the requirements of this standard.
- We explain to our customers how to create the usability file in an efficient way.
- We offer all other usability modules and document these activities in a standard-compliant fashion to allow our customers to directly use these documents for the usability file.
2. Validation & Assessment
- We relieve our customers of the tasks of conception, implementation, and evaluation of usability tests and make sure that these meet the validation provisions according to IEC 62366.
- Based on the test results, we assess the consequences of user errors together with the customer’s risk management officers.
- If required, we can support our customers in redesigning their user interface.
- We prepare the results of validation tests for the usability file.
3. Requirement Analysis
- Analysis of users, tasks, context, and workflow. Strictly according to the following aspects: Who is the user of the product? What are the user’s needs and expectations? What tasks is the user supposed to fulfill by means of this product? What context shall the product be used in?
- Identification, structuring, and prioritization of requirements
4. Conception, Prototyping & Design
- Interaction concepts on the basis of the following questions: How shall the user operate the product? And how shall the user and the product interact with each other?
- Interactive prototypes
- User interface design
Our range of services for you
We develop software for companies wishing to implement their creative ideas and make their business processes more efficient through individual IT solutions.
Because the user alone decides whether a piece of software succeeds or fails.
Being an expert in robotics and AI, we lend you a helping hand for new technologies.
Full speed ahead to the result by means of harmonized development and production processes as well as centralized data management.
IT Service Management
Consistent orientation of your IT toward your business strategy in order to enhance cost efficiency and productivity.